Obstructive Sleep Apnea (OSA)NCT06944782
Diagnosing Obstructive Sleep Apnea Using Electromyography of the Muscles of the Mouth
An observational study of Obstructive Sleep Apnea (OSA) and OSA, run by University of California, San Diego at 1 site in United States.
Trial summary
The investigators will establish how well a novel, quick, and painless way of measuring muscle activity from the mouth and throat works for detecting sleep apnea. This technology is called transmembraneous electromyography (tmEMG). Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Obstructive Sleep Apnea (OSA), OSA, Healthy Volunteers
- What is being tested?
- Electromyography (EMG) of the Oropharynx
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- 24 Mar 2025to Sep 2025
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Study subjects will be recruited from adult patients who have undergone a sleep study, generally within San Diego County.
Who may be able to join
- Age 18 years or older
- Subject must have completed a prior sleep test.
- Subjects may be recruited if the last prior sleep test either determined that they do not have sleep apnea OR they have moderate to severe sleep apnea. No sleep apnea is defined by AHI < 5; moderate to severe sleep apnea is defined by AHI >= 15.
- To be fully eligible, the prior test result needs to be verified via 2-night home sleep test (using the average AHI from the 2 nights). If OSA status (i.e., AHI<5/h or >=15/h) from the 2-night HST vs last prior sleep test is discordant, then participants will be excluded as screen failures.
Who cannot join
- Current use of OSA therapy, including PAP (positive airway pressure) or non-invasive ventilation on a daily basis
- Prior uvulopalatopharyngoplasty surgery for sleep apnea.
- Inability to install WatchPAT ONE application on smartphone or tablet or unwillingness/inability to use the WatchPAT ONE home sleep study device
- Prisoners are excluded due to ethical, legal, and practical concerns
- Individuals who are pregnant are excluded due to temporary changes in habitus, fluid shifts, and potential changes to oropharyngeal musculature may impact tmEMG assessment. This important subpopulation will be investigated in a later phase study.
- Inability to stop tobacco, marijuana, or vaping on the day of testing.
Show all 14Show fewer
- Binge alcohol use behaviors (4+ drinks on the same occasion on 5+ days in the past month).
- Medication use that may cause central apnea that in the judgment of the investigators could impact the safety or results of the study
- Allergy to benzocaine topical anesthetic or other ester class local anesthetics (lidocaine, etc.)
- Current psychiatric illness other than treated mood disorders
- Unable or unwilling to provide informed consent or comply with research procedures
- Active Cancer due to potential interference with study results
- Major comorbidities which in the judgment of the investigators could impact the safety or results of the study
- Inability to sign consent and participate in the study in English. This study involves use of an investigational device; the technical nature of the study and the consenting process and consent form make it impractical to include subjects who cannot participate in English.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of California San Diego
San Diego, California, 92037
Sleep Research Coordinator, 858-246-2154, sleepresearch@health.ucsd.edu
About this study
Official title: BREATH: Breakthrough Research in Electromyography for the Assessment of Sleep-disordered BreaTHing
The investigators will establish how well a novel, quick, and painless way of measuring muscle activity from the mouth and throat works for detecting sleep apnea. This technology is called transmembraneous electromyography (tmEMG). Leveraging two technologies, a new probe capable of recording muscle activity by lightly touching the muscle, as well as a machine learning model for signal interpretation, the investigators will conduct an initial observational feasibility study in phase 1, followed by a larger observational cohort study in phase 2 to assess the performance of deep learning enhanced tmEMG. The study will address a critical unmet need in sleep apnea diagnostics: the availability of an inexpensive, accurate diagnostic test for screening at point of care.
Read the detailed description
Given night-to-night variability and/or changes in OSA severity over time, study participants will undergo a 2-night home sleep test to verify the results of a prior sleep test as part of our screening activities. After verifying that the results of the home sleep test are concordant with the participant's previously administered clinical sleep study, they will be brought to the study clinic. Participants from both arms will undergo testing of four oropharyngeal muscles: left and right palatoglossus, left and right genioglossus. Using the transmembranous electromyography (tmEMG) probe, recordings will be obtained from each muscle using various provocative maneuvers. For the palatoglossus, recordings will be obtained during normal shallow inspiration as well as deep forceful inspiration. For the genioglossus, recordings will be obtained during maximal voluntary contraction as well sub-maximal voluntary contraction of the tongue against resistance (either the buccal mucosa or the front incisors).
- Being tested
- Electromyography (EMG) of the Oropharynx
- Keywords
- sleep study, polysomnography
- Medical subject headings
- Sleep Apnea, Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Electromyography (EMG) of the OropharynxDiagnostic test
Also called transmembranous EMG, tmEMG
The transmembranous electromyography (tmEMG) probe is a disposable single-use bipolar recording device with the sensor configured with two electrodes located at the distal end of the probe in a parallel orientation. Unlike conventional EMG probes that are designed to be inserted into the muscle, the tmEMG probe is placed on the surface of the muscle similar to a surface electrode; the tip of the probe is approximately the size of a ball point pen, which allows us to record from the smaller muscles inside the mouth. Recordings will be taken from the genioglossus and palatoglossus in the mouth bilaterally. Recordings will be taken while the subject performs various maneuvers such as shallow breathing, deep breathing, and pressing their tongue against the side of their mouth.
| Study group | Role | What they receive |
|---|---|---|
| Healthy Controls | Adults who have completed a sleep study but were not diagnosed with sleep apnea. Receives: Diagnostic Test: Electromyography (EMG) of the Oropharynx | |
| People with Sleep Apnea | Adults who have completed a sleep study and were diagnosed with sleep apnea. Receives: Diagnostic Test: Electromyography (EMG) of the Oropharynx |
What is being measured
The primary outcome is the main question the study is designed to answer.
AUC (Area Under the Curve)
Diagnostic accuracy, as measured by the area under the receiver operator characteristic curve (AUC), of DL-tmEMG algorithm in detecting moderate to severe OSA.
Measured: 3 months
Secondary outcomes (1)
Delta AUC When Adding Clinical Data
The secondary outcome is to assess the incremental improvement in diagnostic performance, as measured by the change in AUC, when selected clinical variables are incorporated into the tmEMG-based machine learning model. These clinical variables may include demographic characteristics, sleep-related questionnaire scores (e.g., STOP-Bang, Epworth Sleepiness Scale), and relevant medical history. Model performance with and without clinical variables will be compared using appropriate statistical techniques to evaluate the added predictive value.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Apr 2025
- Study start24 Mar 2025
- Primary completionSep 2025 (estimated)
- Study completionSep 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Obstructive Sleep Apnea (OSA)Studies of the same condition, open and under way.
- More trials run by University of California, San DiegoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of California, San Diego
- Sponsor type
- University, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI), Powell Mansfield Inc.
- Responsible party
- Principal investigator, Jejo Koola, University of California, San Diego
- Investigators
- Jejo Koola, MD, Principal investigator, University of California, San Diego
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06944782
- Sponsor's protocol ID
- 315616-00001
- Other IDs
- R42HL176325-01
- Status last verified
- Apr 2025
- First submitted
- 14 Apr 2025
- Last updated
- 25 Apr 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- BREATH: Breakthrough Research in Electromyography for the Assessment of Sleep-disordered BreaTHing
- ClinicalTrials.gov ID
- NCT06944782
- Acronym / sponsor ID
- 315616-00001
- Keywords
- sleep study, polysomnography
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- University of California, San DiegoUniversity, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI), Powell Mansfield Inc.
- Study start
- 24 Mar 2025 (actual)
- Primary completion
- Sep 2025 (estimated)
- Study completion
- Sep 2025 (estimated)
- First posted
- 25 Apr 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The investigators will establish how well a novel, quick, and painless way of measuring muscle activity from the mouth and throat works for detecting sleep apnea. This technology is called transmembraneous electromyography (tmEMG). Leveraging two technologies, a new probe capable of recording muscle activity by lightly touching the muscle, as well as a machine learning model for signal interpretation, the investigators will conduct an initial observational feasibility study in phase 1, followed by a larger observational cohort study in phase 2 to assess the performance of deep learning enhanced tmEMG. The study will address a critical unmet need in sleep apnea diagnostics: the availability of an inexpensive, accurate diagnostic test for screening at point of care.
Detailed description
Given night-to-night variability and/or changes in OSA severity over time, study participants will undergo a 2-night home sleep test to verify the results of a prior sleep test as part of our screening activities. After verifying that the results of the home sleep test are concordant with the participant's previously administered clinical sleep study, they will be brought to the study clinic. Participants from both arms will undergo testing of four oropharyngeal muscles: left and right palatoglossus, left and right genioglossus. Using the transmembranous electromyography (tmEMG) probe, recordings will be obtained from each muscle using various provocative maneuvers. For the palatoglossus, recordings will be obtained during normal shallow inspiration as well as deep forceful inspiration. For the genioglossus, recordings will be obtained during maximal voluntary contraction as well sub-maximal voluntary contraction of the tongue against resistance (either the buccal mucosa or the front incisors).
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Healthy Controls | – | Diagnostic Test: Electromyography (EMG) of the OropharynxAdults who have completed a sleep study but were not diagnosed with sleep apnea. |
| People with Sleep Apnea | – | Diagnostic Test: Electromyography (EMG) of the OropharynxAdults who have completed a sleep study and were diagnosed with sleep apnea. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Study subjects will be recruited from adult patients who have undergone a sleep study, generally within San Diego County.
Key inclusion criteria (4 listed)
- Age 18 years or older
- Subject must have completed a prior sleep test.
Key exclusion criteria (14 listed)
- Current use of OSA therapy, including PAP (positive airway pressure) or non-invasive ventilation on a daily basis
- Prior uvulopalatopharyngoplasty surgery for sleep apnea.
- Inability to install WatchPAT ONE application on smartphone or tablet or unwillingness/inability to use the WatchPAT ONE home sleep study device
- Prisoners are excluded due to ethical, legal, and practical concerns
- Individuals who are pregnant are excluded due to temporary changes in habitus, fluid shifts, and potential changes to oropharyngeal musculature may impact tmEMG assessment. This important subpopulation will be investigated in a later phase study.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Electromyography (EMG) of the OropharynxAlso: transmembranous EMG, tmEMGThe transmembranous electromyography (tmEMG) probe is a disposable single-use bipolar recording device with the sensor configured with two electrodes located at the distal end of the probe in a parallel orientation. Unlike conventional EMG probes that are designed to be inserted into the muscle, the tmEMG probe is placed on the surface of the muscle similar to a surface electrode; the tip of the probe is approximately the size of a ball point pen, which allows us to record from the smaller muscles inside the mouth. Recordings will be taken from the genioglossus and palatoglossus in the mouth bilaterally. Recordings will be taken while the subject performs various maneuvers such as shallow breathing, deep breathing, and pressing their tongue against the side of their mouth. | Diagnostic test | Healthy Controls, People with Sleep Apnea |
Primary outcome
AUC (Area Under the Curve)
Time frame: 3 months
Diagnostic accuracy, as measured by the area under the receiver operator characteristic curve (AUC), of DL-tmEMG algorithm in detecting moderate to severe OSA.
1 secondary outcome
Delta AUC When Adding Clinical Data
Time frame: 3 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Apr 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Jejo Koola, MD principal investigator
University of California, San Diego
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Obstructive Sleep Apnea (OSA) and OSA, run by University of California, San Diego at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 25 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Sleep Research Coordinator (858-246-2154, sleepresearch@health.ucsd.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
AUC (Area Under the Curve) (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Apr 2025.